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Not Yet Recruiting NCT05731349

Impact of Early Sepsis Care Guided by the National Early Warning Score 2 in the Emergency Department

Conditions: Sepsis, Septic Shock

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 200
Sponsor: The University of Hong Kong

Summary

The goal of this pilot clinical trial is to determine the feasibility of conducting a fully powered type 1 hybrid effectiveness-implementation trial on early sepsis care that is guided by early warning score in adult emergency department (ED) patients who have infection. The main questions it aims to answer are:Is it feasible to execute the trial procedure and fulfill the progression criteria to a full-scale trial?Does the Surviving Sepsis Campaign (SSC) Hour-1 Bundle care reduce the mortality of adult ED patients with a clinical diagnosis of infection and a National Early Warning Score 2 (NEWS2) equal to or greater than 5?What are the barriers to and facilitators of the implementation of the SSC Hour-1 Bundle in the ED settings?Participants will receive the following SSC Hour-1 Bundle care during the intervention period:Blood lactate level measurementBlood cultures collection before administering antibioticsBroad-spectrum antibioticsIntravenous fluidVasopressors if the blood pressure remains low during or after fluid replacement to maintain the mean arterial blood pressure equal to or greater than 65 mmHgResearchers will compare patients who receive SSC Hour-1 Bundle triggered by a NEWS2 equal to or greater than 5 and patients who receive standard treatment based on clinical judgement to see if the SSC Hour-1 that is triggered by a high NEWS2 score could reduce mortality of adult ED patients with infection.

Eligibility Criteria

Inclusion Criteria:ED patients aged ≥ 18 years who fulfil ALL of the following criteria:a clinical diagnosis of infection made by the treating emergency physiciansrequire hospital admissiona NEWS2 ≥ 5Exclusion Criteria:age < 18 yearscurrently pregnantneutropenic or post-chemotherapy fever, for which ED protocols for early antibiotics applyan advanced directive with a ceiling-of-carerefusal of consent/pre-existing mental illness rendering consent impossiblerefusal of hospitalization

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05731349). StuddyBuddy aggregates publicly available trial information.